VistaPharm LLC Issues Voluntary Nationwide Recall of Sucralfate Oral Suspension, 1g/10mL Due to Microbial Contamination Identified as Bacillus Cereus
FOR IMMEDIATE RELEASE – September 22, 2023 – Largo, Florida, VistaPharm LLC is voluntarily recalling one (1) lot of Sucralfate Oral Suspension, 1g/10mL, to the consumer level, due to Bacillus cereus contamination in the product.
Risk Statement: In the population most at risk, the immunocompromised population, there is a reasonable probability that microbial contamination of the oral suspension can result in disseminated, life threatening infections such as endocarditis and necrotizing soft tissue infections. To date, VistaPharm LLC has not received any reports of adverse events related to this recall.
The product is used as an antiulcer therapeutic and is packaged in a 16oz (414mL) PET Bottle with NDC 66689-305-16. The affected Sucralfate Oral Suspension lot is number 810300 with an expiration Date of October 31, 2023. The product can be identified with its product name Sucralfate Oral Suspension 1g per 10mL, which the product Lot No 810300 and expiration date of October 31, 2023, at the bottom right side of label. This Sucralfate Oral Suspension Lot was distributed Nationwide to three (3) distributors by wholesale.
Food & Beverage Recalls
Safeway Fresh Foods Recalls Sunnyside Farms Organic Butternut Squash Because of Possible Health Risk
Safeway Fresh Foods of Vineland, NJ, is recalling its 32-oz. Diced Organic Butternut Squash product as it has the potential to be contaminated with Escherichia coli O45. E. coli O45 causes a diarrheal illness often with bloody stools. Although most healthy adults can recover completely within a week, some people develop a form of kidney failure called Hemolytic Uremic Syndrome (HUS). HUS is most likely to occur in young children and the elderly; the condition can lead to serious kidney damage and even death.
The 32-oz. diced Butternut was distributed only to Costco in the following states, Washington DC, Maryland, Pennsylvania, and Virgina
Consumers who specifically purchased Costco item 20522, UPC 040232244124, 32-oz. diced Organic Butternut Squash between September 7, 2023, and September 15, 2023, with a use by date of 09/19/2023 date code are urged to return this item to your local Costco. If you have any product with this date code remaining, do not consume.
Medical Device Recalls
Universal Meditech Inc. Expands Nationwide Recall to All Products Manufactured between March 2021 and November 2022
On May 22, 2023, Universal Meditech Inc. initiated a nationwide recall of products it manufactured between March 2021 and November 2022. The recall is due to the reasons that:
- The company is going out of business, hence would not be able to continue fulfilling any post-market responsibilities of these distributed products.
- Four of the products (PrestiBio Breastmilk Alcohol Test Strip, PrestiBio™ Ketone Test Strips, HealthyWiser KetoFast™ Ketone Test Strips and DiagnosUS® SARS-CoV-2 Antibody (IgG/IgM) Test) have been violatively distributed without appropriate premarket clearance or approval which potentially could result in inaccurate test results due to lack of performance evaluation by the FDA.